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Recruiting NCT06424327

A Registry for People With Lung Cancer

Observational Lung Cancer Lung Cancer Stage I

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient-Reported Outcomes Measurement Information System.
Who it may be relevant to
Registry conditions: Lung Cancer, Lung Cancer Stage I. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Pulmonary Segmentectomy for Lung Cancer: A Real-World International Registry-TSOG 108

Overview

Participants will complete questionnaires before surgery, between 2 to 4 weeks after surgery, and 6 months after surgery.

Interventions

  • Other Patient-Reported Outcomes Measurement Information System
    Participants-reported outcomes will be collected using the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS is a web-based platform developed by the National Institutes of Health. Scoring is standardized on a scale from 0 to 100, with a population mean of 50 and standard deviation of 10 units. High scores mean more of the concept being measured. This study will use PROMIS surveys assessing three domains: physical function (PROMIS bank version 2.0), pain interference (PRO

Primary outcome measures

  • Determine 3-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer. [Time frame: 3 years]
  • Determine 5-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer. [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years
  • Patients suitable for segmentectomy, according to the treating surgeon
  • Clinical Stage I with suspected NSCLC, classified preoperatively based on the AJCC TNM staging manual, 9th edition o Note: Tissue diagnosis of NSCLC is not required before enrollment. A pathologic diagnosis of NSCLC may be confirmed preoperatively with biopsy, intraoperatively with frozen section, or postoperatively on final pathology

Exclusion criteria

  • Actively receiving lung cancer treatment or a history of lung cancer in the previous 5 years
  • History of chemotherapy or radiation therapy for a previous lung cancer
  • Synchronous secondary cancer in the lung or elsewhere in the body at the time of surgery
  • Carcinoid tumors
  • History of other malignancies within the past 3 years, with the exception of non-melanoma skin cancer, superficial bladder cancer, and carcinoma in situ of the cervix
  • Actively receiving treatment for other malignancies
  • Cases of lobectomy in conjunction with segmentectomy from another lobe and ≥2 segmentectomies from different lobes either en bloc or separate will be excluded from the primary analysis.
  • Multi-segmental resection from the same lobe is not a criterion for exclusion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 16 centers
  • University of Arizona (Data Collection Only) — Tucson
  • University of California San Diego (Data collection) — San Diego
  • Rush University Medical Center (Data collection only) — Chicago
  • Endeavor Health — Evanston
  • University of Michigan (Data Collection Only) — Ann Arbor
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
  • … and 8 more centers
Canada · 2 centers
  • University Health Network (Data Collection Only) — Toronto
  • Centre Hospitalier de l'Université de Montreal (Data Collection Only) — Montreal

Identifiers

NCT: NCT06424327 · 24-127

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗